BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6052440 · Received October 24, 2016

    Report

    Report Number
    3008011247-2016-00117
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2680I1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT UNDERWENT AAA REPAIR USING AN ENDURANT ABDOMINAL STENT GRAFT APPROXIMATELY 3 YEARS PRIOR TO THE EVENT. THE 3 YEAR ROUTINE FOLLOW-UP CT SHOWED THE PRESENCE OF A TYPE IA ENDOLEAK. AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM AND A MEDTRONIC AORTIC CUFF WAS IMPLANTED TO RE-LINE THE ENDURANT STENT GRAFT AND TREAT THE ENDOLEAK. THE FINAL ANGIOGRAM SHOWED THE PRESENCE OF AN AORTIC RUPTURE; IT WAS NOTED THAT THE AORTIC CUFF MALFUNCTIONED UPON DEPLOYMENT. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN SURGICAL REPAIR, AND THE PATIENT SUBSEQUENTLY EXPIRED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702667 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-I FS032816-13 M701TVAB2680I1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R MEDTRONIC AORTIC CUFF